ANDA Approvals of Q3 - Fall 2023 | Hatch-Waxman

New Drug Applications and 505(b)(2) Applications

Third Quarter

This ANDA Approvals chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA.

Approval Date	Reference Listed Drug	Generic Drug Name	ANDA Holder	ANDA Applicant
07/03/2023	Trileptal	Oxcarbazepine	Novartis	Zydus
07/03/2023	Pylera	Bismuth Subcitrate Potassium / Metronidazole / Tetracycline HCl	AbbVie	Riconpharma
07/05/2023	Jevtana Kit	Cabazitaxel	Sanofi	Mylan
07/05/2023	Immodium A-D	Loperamide HCl	Johnson & Johnson	Jubilant Cadista
07/06/2023	Vivitrol	Naltrexone	Alkermes	Teva
07/06/2023	Antizol	Fomepizole	Par	Gland Pharma
07/07/2023	Viibryd	Vilazodone HCl	AbbVie	Apotex
07/07/2023	Hexadrol	Dexamethasone Sodium Phosphate	Aspen Global	Geneyork Pharms
07/07/2023	Nicardipine Hydrochloride	Nicardipine HCl	Hikma	Micro Labs
07/07/2023	Pepsid	Famotidine	Salix	Carnegie
07/10/2023	Rozerem	Ramelteon	Takeda	Aurobindo
07/10/2023	Advil Dual Action with Acetaminophen	Acetaminophen / Ibuprofen	Glaxo	Marksans Pharma
07/10/2023	Leucovorin Calcium	Leucovorin Calcium	Hospira	Hainan Poly
07/11/2023	Benicar	Olmesartan Medoxomil	Cosette	Amneal
07/11/2023	Renagel	Sevelamer HCl	Genzyme	Aurobindo
07/11/2023	Macrobid	Nitrofurantoin (Monohydrate / Macrocrystals)	Almatica	Mankind
07/11/2023	Sterile water for Injection	Sterile water for Injection	Hospira	Nexus
07/11/2023	Xylocaine	Lidocaine HCl	Fresenius Kabi	Mankind
07/11/2023	Sodium Chloride	Sodium Chloride 23.4%	Abraxis	Fresenius Kabi
07/12/2023	Lyrica	Pregabalin	Upjohn	Cadila Pharms
07/12/2023	Potassium Chloride	Potassium Chloride	Pharma Res Software	Novitium Pharma
07/12/2023	Nexium 24 hour	Esomeprazole Magnesium	AstraZeneca	Aurobindo
07/12/2023	MetroGel-Vaginal	Metronidazole	Bausch	Cosette
07/13/2023	Chlorpromazine HCl	Chlorpromazine HCl	Upsher-Smith	Lupin
07/13/2023	Oxtellar XR	Oxcarbazepine	Supernus	Apotex
07/13/2023	Advil Dual Action with Acetaminophen	Acetaminophen / Ibuprofen	Glaxo	Granules
07/13/2023	Steglatro	Ertugliflozin	Pfizer / Merck	Aurobindo
07/14/2023	Otezla	Apremilast	Amgen	Dr Reddys Labs
07/14/2023	Iclusig	Ponatinib HCl	Takeda	Apotex
07/14/2023	Zebeta	Bisoprolol Fumarate	Teva	Prinston
07/14/2023	Sodium Phenylacetate / Sodium Benzoate	Sodium Phenylacetate / Sodium Benzoate	Maia Pharms	Navinta
07/17/2023	Cytoxan	Cyclophosphamide	Baxter Healthcare	Sagent Pharms
07/17/2023	Cortef	Hydrocortisone	Pharmacia and Upjohn	Aurobindo
07/17/2023	Cardine	Nicardipine HCl	Chiesi	Senores Pharms
07/18/2023	Chlorpromazine HCl	Chlorpromazine HCl	Upsher-Smith Labs	Alembic
07/19/2023	Otezla	Apremilast	Amgen	Aurobindo
07/19/2023	Leucovorin Calcium	Leucovorin Calcium	Hospira	Kindos
07/19/2023	Neurontin	Gabapentin	Viatris	Rising
07/24/2023	Mozobil	Plerixafor	Genzyme	Dr Reddys Labs
07/24/2023	Mozobil	Plerixafor	Genzyme	Teva
07/24/2023	Mozobil	Plerixafor	Genzyme	MSN
07/24/2023	Bumex	Bumetanide	Validus Pharms	Taro
07/24/2023	Mozobil	Plerixafor	Genzyme	Eugia Pharma
07/24/2023	Aggrastat	Tirofiban HCl	Medicure	Nexus
07/24/2023	Mozobil	Plerixafor	Genzyme	Amneal
07/24/2023	Mozobil	Plerixafor	Genzyme	Kindos
07/25/2023	Ranexa	Ranolazine	Gilead	Piramal
07/25/2023	Hemabate	Carboprost Tromethamine	Pfizer	Steriscience
07/25/2023	Chantrix	Varenicline Tartrate	PF Prism	Medley Pharms
07/26/2023	Mozobil	Plerixafor	Genzyme	Zydus
07/26/2023	Otezla	Apremilast	Amgen	Annora
07/27/2023	Inomax	Ulspira - Nitric Oxide	Mallinckrodt	Airgas Therapeutics
07/27/2023	Zithromax	Azithromycin	Pfizer	Hainan Poly
07/27/2023	Tobi	Tobramycin	Mylan	Micro Labs
07/28/2023	Rocaltrol	Calcitriol	Validus Pharms	Patrin
07/28/2023	Claritin	Loratadine	Bayer	Hetero Lab
07/28/2023	Azopt	Brinzolamide	Novartis	Padagis
07/28/2023	Mephyton	Phytonadione	Bausch Health	Sciegen Pharms Inc
07/28/2023	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	Fresenius Kabi	Gene York Pharms
07/31/2023	LO/Ovral-28	Turqoz	Wyeth	Lupin
07/31/2023	Onglyza	Saxagliptin HCl	AstraZeneca	Amneal
07/31/2023	Onglyza	Saxagliptin HCl	AstraZeneca	Aurobindo
07/31/2023	Onglyza	Saxagliptin HCl	AstraZeneca	Mylan
07/31/2023	Kombiglyze ER	Saxagliptin / Metformin HCl	AstraZeneca	Mylan
07/31/2023	Onglyza	Saxagliptin HCl	AstraZeneca	Glenmark
07/31/2023	Onglyza	Saxagliptin HCl	AstraZeneca	Sun
07/31/2023	Kombiglyze ER	Saxagliptin / Metformin HCl	AstraZeneca	Sun
07/31/2023	Derma Smooth/FS	Fluocinolone Acetonide	Hill Dermac	Novel Labs
07/31/2023	Argatroban	Argatroban	Hikma	Gland Pharma
08/01/2023	Permethrin	Permethrin	Aurobindo	Dr Reddys Labs
08/01/2023	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	Fresenius Kabi	Hikma
08/01/2023	Chantix	Varenicline Tartrate	PF Prism	Mankind Pharma
08/01/2023	Alphagan P	Brimonidine Tartrate	AbbVie	Alembic
08/01/2023	Advil Dual Action with Acetaminophen	Acetaminophen / Ibuprofen	Glaxo	Bionpharma
08/01/2023	Mucinex DM	Guaifenesin / Dextromethorphan Hydrobromide	Reckitt Benckiser	Dr Reddys Labs
08/02/2023	Indocin	Indomethacin	Zyla Life Sciences	Zydus
08/03/2023	Aptiom	Eslicarbazepine Acetate	Sumitomo Pharma	Hetero Labs
08/03/2023	Revlimid	Lenalidomide	Celgene	Torrent
08/03/2023	Zyloprim	Allopurinol	Casper Pharma	Hetero Lab
08/04/2023	Xiidra	Lifitegrast	Novartis	Micro Labs
08/04/2023	Diclegis	Doxylamine Succinate / Pyridoxine HCl	Duchesnay	Bionpharma
08/04/2023	Vancomycin HCl	Vancomycin HCl	Mylan	Eugia Pharma
08/04/2023	Bentyl	Dicyclomine HCl	Allergan	Bionpharma
08/07/2023	Derma-Smooth/FS	Fluocinolone Acetonide	Hill Dermac	Novel Labs
08/07/2023	Methotrexate Sodium	Methotrexate Sodium	Strides	Daito
08/07/2023	Toprol XL	Metoprolol Succinate	Toprol	Granules
08/07/2023	Denavir	Penciclovir	Mylan	Torrent
08/07/2023	Intuniv	Guanfacine HCl	Takeda	Alembic
08/07/2023	Hemabate	Carboprost Tromethamine	Pfizer	Gland Pharma
08/08/2023	Children's Motrin	Ibuprofen	Johnson & Johnson	Taro Pharms
08/09/2023	Kombiglyze XR	Metformin HCl / Saxagliptin HCl	AstraZeneca	Dr Reddys Labs
08/09/2023	Lotemax	Loteprednol Etabonate	Bausch and Lomb	Sun
08/09/2023	Paraflex	Chlorzoxazone	Ortho McNeil	Graviti Pharms
08/10/2023	Lioresal	Baclofen	Amneal	Acic Pharms
08/11/2023	Diovan HCT	Valsartan / Hydrochlorothiazide	Novartis	Amneal
08/11/2023	Doryx MPC	Doxycycline Hyclate	Mayne Pharma	Lupin
08/11/2023	Lexette	Halobetasol Propionate	Mayne Pharma	Padagis
08/14/2023	Firazyr	Icatibant Acetate	Takeda	Eugia Pharma
08/14/2023	Aloxi	Palonosetron HCl	Helsinn Healthcare	Nanjing King-Friend
08/14/2023	Cozaar	Losartan Potassium	Organon	MSN Labs
08/14/2023	Potassium Chloride for Injection Concentrate	Potassium Chloride	Hospira	Nexus Pharms
08/14/2023	Lithium Citrate Syrup	Lithium Citrate	Hikma	Rubicon
08/15/2023	Bromday	Bromfenac Sodium	Bausch and Lomb	Lupin
08/15/2023	Toprol XL	Metoprolol Succinate	AstraZeneca	Lupin
08/15/2023	Trokendi XR	Topiramate	Supernus Pharms	Ajanta
08/15/2023	Thiola EC	Tiopronin	Mission Pharmacal	Amneal
08/15/2023	Aventyl	Nortriptyline HCl	Ranbaxy	Rubicon
08/16/2023	Silenor	Doxepin HCl	Currax	Zydus
08/16/2023	Zonalon	Doxepin HCl	Mylan	Amneal
08/16/2023	Balcoltra	Levonorgestrel / Ethinyl Estradiol / Ferrous Fumarate	Avion Pharms	Xiromed
08/17/2023	Selzentry	Maraviroc	ViiV Healthcare	I 3 Pharms
08/17/2023	Pepcid	Famotidine	Salix	Annora
08/17/2023	Hydroxyzine HCl	Hydroxyzine HCl	Pliva	Graviti Pharms
08/18/2023	Ultane	Sevoflurane	AbbVie	Shandong
08/18/2023	D.H.E. 45	Dihydroergotamine Mesylate	Bausch Health	Gland Pharma
08/18/2023	Prolixin	Fluphenazine HCl	Bristol-Myers Squibb	Aurobindo
08/21/2023	Atacand	Candesartan Cilexetil	ANI Pharms	Prinston
08/21/2023	Morphine Sulfate	Morphine Sulfate	Hikma	SpecGx
08/21/2023	Calcium Gluconate	Calcium Gluconate	Fresenius Kabi	B Braun Medical
08/21/2023	Versed	Midazolam HCl	HLR Technology	Micro Labs
08/21/2023	Mucinex	Guaifenesin	Reckitt Benckiser	Marksans Pharma
08/21/2023	Sinequan	Doxepin HCl	Pfizer	Unique Pharm
08/21/2023	Sutent	Sunitinib Malate	CPPI	Novugen
08/22/2023	Retin-A Micro	Tretinoin Microsphere	Valeant	Encube
08/22/2023	Zinc Sulfate	Zinc Sulfate	America Regent	Zydus
08/23/2023	Esbriet	Pirfenidone	Genentech	Lupin
08/23/2023	Chantix	Varenicline Tartrate	PF Prism CV	Alkem
08/23/2023	Invega	Paliperidone	Janssen	Ascent Pharms
08/23/2023	Bacteriostic Sodium Chloride	Sodium Chloride 0.9%	Hospira	Nexus Pharms
08/23/2023	Dexamethasone	Dexamethasone	Hikma	Apotex
08/24/2023	Divigel	Estradiol	Vertical Pharms	Novitium
08/24/2023	Restoril	Temazepam	SpecGx	Alkem Labs
08/25/2023	Vyvanse	Lisdexamfetamine Dimesylate	Takeda	Actavis Elizabeth
08/25/2023	Vyvanse	Lisdexamfetamine Dimesylate	Takeda	Hikma
08/25/2023	Vyvanse	Lisdexamfetamine Dimesylate	Takeda	Amneal
08/25/2023	Vyvanse	Lisdexamfetamine Dimesylate	Takeda	Mylan
08/25/2023	Vyvanse	Lisdexamfetamine Dimesylate	Takeda	SpecGx
08/25/2023	Niaspan	Niacin	AbbVie	Eywa
08/25/2023	Vyvanse	Lisdexamfetamine Dimesylate	Takeda	Sun
08/25/2023	Vyvanse	Lisdexamfetamine Dimesylate	Takeda	Sun
08/25/2023	Vyvanse	Lisdexamfetamine Dimesylate	Takeda	Norwich
08/25/2023	Combigan	Brimonidine Tartrate / Timolol Maleate	AbbVie	Alembic
08/25/2023	Vyvanse	Lisdexamfetamine Dimesylate	Takeda	Rhodes
08/25/2023	Vyvanse	Lisdexamfetamine Dimesylate	Takeda	Teva
08/25/2023	Vyvanse	Lisdexamfetamine Dimesylate	Takeda	Lannett
08/25/2023	Vyvanse	Lisdexamfetamine Dimesylate	Takeda	Prinston
08/25/2023	Vyvanse	Lisdexamfetamine Dimesylate	Takeda	Apotex
08/25/2023	Vyvanse	Lisdexamfetamine Dimesylate	Takeda	Ascent Pharms
08/25/2023	Vyvanse	Lisdexamfetamine Dimesylate	Takeda	Alkem Labs
08/25/2023	Concerta	Methylphenidate HCl	Johnson & Johnson	Sun
08/25/2023	Xelganz	Tofacitinib	PF Prism	Sun
08/25/2023	Vyvanse	Lisdexamfetamine Dimesylate	Takeda	Ascent Pharms
08/28/2023	Esbriet	Pirfenidone	Genentech	Lupin
08/28/2023	Effient	Prasugrel HCl	Cosette	Unichem
08/28/2023	Ibrance	Palbociclib	Pfizer	Synthon
08/28/2023	Noxafil	Posaconazole	Merck Sharp Dohme	I 3 Pharms
08/29/2023	Accutane	Isotretinoin	Takeda	Zydus
08/29/2023	CellCept	Mycophenolate Mofetil	Roche	Strides
08/29/2023	Viagra	Sildenafil Citrate	Viatris	Novitium
08/29/2023	Sterile water for Injection	Sterile water for Injection	Hospira	American Regent
08/30/2023	Bentyl	Dicyclomine Hydrochloride	Allergan	Prinston
08/31/2023	Mydayis	Dextroamphetamine Saccharate / Amphetamine Aspartate Monohydrate / Dextroamphetamine Sulfate / Amphetamine Sulfate	Takeda	Specgx
08/31/2023	Entereg	Alvimopan	Cubist	Hikma
09/08/2023	Gadavist	Gadobutrol	Bayer	Jiangsu Hengrui
09/11/2023	Diamox	Acetazolamide	Teva	Ajanta Pharma
09/11/2023	CellCept	Mycophenolate Mofetil	Roche	Airis Pharma
09/11/2023	Prolixin	Fluphenazine HCl	Bristol-Myers Squibb	MSN Labs
09/12/2023	Lipitor	Atorvastatin Calcium	Upjohn	Hetero Labs
09/13/2023	Augmentin	Amoxicillin / Clavulanate Potassium	US Antibiotics	Deva Holding
09/14/2023	Prezista	Darunavir	Janssen	Hetero Labs
09/14/2023	Ortho Evra	Ethinyl Estradiol / Norelgestromin	Janssen	Zydus
09/14/2023	Advil Liqui-Gels	Ibuprofen	Glaxo	Aurobindo
09/14/2023	Librax	Chlordiazepoxide HCl / Clidinium Bromide	Bausch Health	Aurobindo
09/14/2023	Famotidine	Famotidine	Novitium Pharma	Micro Labs
09/15/2023	Augmentin	Amoxicillin / Clavulanate Potassium	US Antibiotics	Deva Holding
09/15/2023	Librax	Chlordiazepoxide HCl / Clidinium Bromide	Bausch Health	Alembic
09/15/2023	Levophed	Norepinephrine Bitartrate	Hospira	Caplin Steriles
09/18/2023	Pepcid	Famotidine	Salix	Ajanta
09/19/2023	Cleosin T	Clindamycin Phosphate	Pfizer	Cadila Healthcare
09/21/2023	Diflucan	Fluconazole	Pfizer	Hainan Poly
09/21/2023	Mestinon	Pyridostigmine Bromide	Bausch Health	MSN Labs
09/22/2023	Tegretol -;XR	Carbamazepine	Novartis	Amneal
09/22/2023	Vascepa	Icosapent Ethyl	Amarin	Strides
09/25/2023	AK-Fluor	Fluorescein Sodium	Long Grove Pharms	Nexus Pharms
09/25/2023	Xeljanz	Tofacitinib Citrate	Pfizer	Slayback
09/25/2023	Tapazole	Methimazole	King Pharms	Bionpharma
09/26/2023	Depakote ER	Divalproex Sodium	AbbVie	Annora Pharma
09/26/2023	Velcade	Bortezomib	Takeda	Scinopharm
09/27/2023	Ranexa	Ranolazine	Gilead	Novast Labs
09/27/2023	Topamax	Topiramate	Janssen	Aurobindo
09/27/2023	Mydayis	Dextroamphetamine Saccharate / Amphetamine Aspartate Monohydrate / Dextroamphetamine Sulfate / Amphetamine Sulfate	Takeda	Sun
09/28/2023	Uloric	Febuxostat	Takeda	Macleods
09/28/2023	Aubagio	Teriflunomide	Sanofi	Sola Pharms
09/29/2023	Nexium 24 hour	Esomeprazole Magnesium	AstraZeneca	Marksans Pharma
09/29/2023	Hyzaar	Losartan Potassium / Hydrochlorothiazide	Organon	Granules
09/29/2023	Vasopressin in Sodium Chloride Injection	Vasopressin in Sodium Chloride Injection	Endo / Par	Baxter Healthcare